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From Bedside Observation…. How it beganHow it began What evolvedWhat evolved What is the dataWhat is the data What was our responsibilityWhat was our responsibility What comes nextWhat comes next

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Initial Cleveland Clinic Awareness to Action Mid-2011 Concern about possible increasing incidence of pump thrombosis Formation of a “Thrombosis” group lead by Thoratec Last meeting of this group in Atlanta (2/15/2013) several implanting institutions report similar concern 2/22/2013 Chair requests thorough investigation of CCF experience

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Single Center Data submitted for Publication May 2013 The principal shortcoming of your study is that it is based on the experience of a single center. All of the reviewers of your manuscript raised this issue in their comments to the editors. In order to publish your work, we will need solid confirmation of your findings from the experience of other centers, registries, or data bases. There is concern that center- specific characteristics or practices at Cleveland Clinic may be at play, and it is essential that your study include a much broader dataset in order to provide confirmation/validation of the findings at your center. The editors believe that your findings are interesting and potentially quite important. With that said, we do not want to take a chance on misleading the medical community without convincing validation of your findings.The principal shortcoming of your study is that it is based on the experience of a single center. All of the reviewers of your manuscript raised this issue in their comments to the editors. In order to publish your work, we will need solid confirmation of your findings from the experience of other centers, registries, or data bases. There is concern that center- specific characteristics or practices at Cleveland Clinic may be at play, and it is essential that your study include a much broader dataset in order to provide confirmation/validation of the findings at your center. The editors believe that your findings are interesting and potentially quite important. With that said, we do not want to take a chance on misleading the medical community without convincing validation of your findings. In order to publish your work, we will need solid confirmation of your findings from the experience of other centers, registries, or data bases. There is concern that center- specific characteristics or practices at Cleveland Clinic may be at play, and it is essential that your study include a much broader dataset in order to provide confirmation/validation of the findings at your center.In order to publish your work, we will need solid confirmation of your findings from the experience of other centers, registries, or data bases. There is concern that center- specific characteristics or practices at Cleveland Clinic may be at play, and it is essential that your study include a much broader dataset in order to provide confirmation/validation of the findings at your center. Statistical Reviewer Comments for the Author: This paper reports a dramatic and alarming increase in Heartmate II pump thrombosis after September, 2011 at the Cleveland Clinic. This is important information that should be shared widely.Statistical Reviewer Comments for the Author: This paper reports a dramatic and alarming increase in Heartmate II pump thrombosis after September, 2011 at the Cleveland Clinic. This is important information that should be shared widely.